In a general sense, there are a variety of indications in medicine in which as a portion of the treatment, the skin is punctured, a body cavity such as the pleural space or peritoneum is accessed by a hollow tube, and a liquid or a gas is introduced into or withdrawn from that body cavity.
The thorax or chest cavity of a person contains the lungs as well the mediastinum which holds both the heart and its associated major vessels. The lungs are in turn contained within a pair of pleural sacs or cavities within the thorax.
Breathing takes place as the chest expands and the lungs are filled with air through the contraction of a variety of inspiratory and expiratory muscles The diaphragm, which is the muscle transecting the body cavity below the pleural spaces, is the principal muscle of inspiration and provides for the movement of more than two-thirds of the air that enters lungs during normal or quiet breathing Contraction of the diaphragm causes its muscular domes to descend and the chest to expand along its length. At the same time, because of vertically oriented attachments of the diaphragm to the rib cage edges, its contractions also elevate the lower ribs. The expiratory muscles are typically those found between the ribs.
It is essential that the pleural sac containing the lungs always be intimately connected with the diaphragm and thoracic walls. Or said another ways if the diaphragm moves and the pleural sac does not, a separation has occurred and the lung does not expand with air. It is this separation that is the condition of pneumothorax. Pneumothorax is the condition where air or other gas is present in at least one of the pleural cavities and therefore prevents expansion of the lung. Pneumothorax occurs for a variety of reasons, including disease, injury to the lung tissue, or puncture of the chest wall. In aggravated circumstances, if the partial vacuum is not restored to the pleural cavities, pneumothorax can eventually be fatal.
There are a number of widely known methods for treating pneumothorax that typically involve introducing a chest tube between a pair of ribs into the pleural cavity having the problem. The tube is usually affixed to the chest wall and connected to a vacuum source for evacuating the chest cavity. This regimen allows the patient to breathe while the cause for the malady is investigated and treated. Although the generic method is widely accepted and practiced, there is no commercial device or specific method which is entirely satisfactory for retaining the chest tube.
There are a variety of ways to hold such an apparatus in place. A classical method involves the simple suturing of the device to the skin. That is to say, a loop of suture thread is passed around the device and that thread is then sewed into the skin at a point near the entry site. Often two such loops are provided to allow better anchoring of the device. Such a practice is typical with tube thoracostomies in which the device is sutured to the skin, packed with gauze, and taped down. However, such an arrangement causes both irritation at the stitch site(s) on the skin and is not failsafe in that it allows slippage of the tube upon movement of the patient. Further, when the tube is to be moved or re-positioned, the stitches, tape, and gauze often must be removed and replaced after movement of the tube is accomplished. The methods using suture and gauze packed with tape are also often problematical in that they are prone to leakage, e.g., in a pneumothorax the suction applied to the tube is by-passed via the leakage at the wound site. In addition, the suture thread, if strained forcefully enough, may tear traumatically through the tissue near the entry site.
Other methods of treating pneumothorax involve the introduction of devices such as are shown U.S. Pat. No. 4,813,941, to Shea. Such device has a large hypodermic needle having elongated shaft and a point for penetrating the skin into the selected pleural cavity. The needle is attached to an exhaustion device having a one-piece outer housing which has a one-way valve for exhausting fluid from the pleural cavity and preventing fluid from returning thereto. The device may have a pair of wings projecting longitudinally from the valve head to allow taping of the device to the human body.
Other methods involve the use of needles inserted into the affected pleural cavity in connection to a vacuum and one-way valve device and even conventional hypodermic syringes.
Another device is shown in U.S. Pat. No. 4382,442, to Jones, which is a pump tube apparatus having valves at each end double walled pump for withdrawing fluids from the pleural cavity upon imposition of suction at the proximal end of the device.
The treatment of hemothoraxe, those instances in which the pleural cavity is filled with blood, is also done by tube thoracostomy. Occasionally, chylothorax, the accumulated of a milky (or chylous) fluid, occurs as a result of cardiovascular surgery, particularly of the great vessels. Some consider the triad of trauma, tuberculosis, and tumor (particularly a lymphoma) as a possible cause of that effect. As a portion of the treatment, the chylothorax is drained and other treatment to transpire. Hemopneumothorax, the presence of blood and air in the pleural space, is also known and is usually caused by trauma, e.g., car accidents, stab wounds, and gunshot wounds.
The other instances in which body cavities are entered by tubing and the like, include peritoneal dialysis, penetration of the walls of the bladder, the stomach, segments of the gastrointestinal tract, or placement of catheters into the cardiovascular systems. Various designs of Trocar are also known in the medical arts.
A wide variety of other devices for holding these drains or tubes in place are known.
U.S. Pat. No. 3,241,554 to Coanda, shows a device for passing through an abdominal wall of a patient to allow peritoneal dialysis to be performed. Specifically, the device involves a pair of coaxial tubes which pass through the peritoneal wall. The two tubes are configured in such a fashion that when the inner tube is pulled in relationship to the outer tube, strips formed of the tubes form wings which bend outward from the tubes and nestle on the inside of the abdominal wall. The two tubes pass through the peritoneal wall and are met at the outside by a set of locking members.
Similarly, U.S. Pat. No. 5,232,453, to Plass et al., shows a catheter holder. The holder has a pad of medical grade adhesive material having one surface for attachment to the skin of a wearer. On the side of the adhesive material opposite the skin may be found a pair of tapes arranged in such a way that the two tapes can be stuck together and also stuck to a catheter which passes through an optional aperture or slit between the tapes. The tape is said to be multiple-use tape so that the catheter may be readjusted as may be found necessary.
U.S. Pat. No. 5,242,415, to Kantrowitz et al., shows a percutaneous access device which is a body of relatively soft, flexible, biocompatible material having a base flange and a projection which projects vertically from the top of the base flange. The upwardly extending body and the base flange each have a bore extending vertically through them. The flange appears to be mounted interior to the skin of a patient and the upward projection is configured in such a way that it easily bends as the tube passing through the device is pulled. The tube is sealed within the device bore only near the bottom end of the bore.
U.S. Pat. No. 4,069,826, to Sessions et al., shows a surgical tube adaptor clamp to facilitate entry of an elongated tube having an outer free curved end suitable for insertion into an opening in a blood vessel or the like. The tube adaptor has flat sidewalls and a bore through which may be placed a length of flexible tubing. The device, after emplacement, passes through a pad 17 which is placed against the skin. The sleeve which enters the body lumen is configured in such a way that it buckles after placement in the blood stream and after retraction of an outer section of the tube. In this way there is efficient seal between the tube and the skin.
U.S. Pat. No. 5,092,850, to Buma, shows a catheter having an adjustable external locking bolster. The external surface of the catheter appears to be threaded to allow adjustment of an external coupling having a locking element which prevents slippage.
U.S. Pat. No. 5,221,265, to List, shows an attachment patch suitable for fastening a variety of medical devices to the human skin. The device includes a carrier material having a pressure sensitive adhesive layer and a protective layer covering the pressure sensitive adhesive The material is cut into fastening strips in such a way that the strips may be lifted from the planar patch and wrapped around a catheter or canula to prevent its movement when inserted through the human skin.
U.S. Pat. No. 5,224,935, to Hollands, shows a catheter retainer having an adhesive pad with projections. The pad is made of a medical grade adhesive material having a hole therethrough. The central circular hole has two members which extend away from the human skin and approximately parallel the catheter access as the catheter exits that hole. Thread may be attached to those members and be wound around the catheter a number of times and tied to the other member.
None of these documents show devices which readily allow adjustment of the tube passing through the skin if and when such movement is necessary.